Home Intravenous Fluid Infusion After Undergoing Radical Cystectomy
Home Intravenous Fluid Infusion After Undergoing Radical Cystectomy: A Randomized Controlled Trial
Johns Hopkins University
130 participants
Nov 1, 2025
INTERVENTIONAL
Conditions
Summary
Radical cystectomy is the standard of care for muscle invasive bladder cancer, however despite advances, it is still associated with high morbidity. Many complications may be driven by dehydration and it is unclear if a home intravenous fluid (IVF) infusion program post-operatively, which is an accepted standard practice, is beneficial. This study is a single institution randomized controlled trial where patients who choose to undergo radical cystectomy for bladder cancer will be randomized to an Enhanced Recovery After Surgery (ERAS) protocol with a home IVF program, consisting of 1 liter (L) of crystalloid fluid three times per week for four weeks, or ERAS protocol alone. The primary outcome will be 90-day hospital re-admissions, with secondary outcomes including 30 and 90 day complications.
Eligibility
Inclusion Criteria3
- Adult patients greater than 18 years of age and older
- Confirmed urothelial carcinoma on pathology, including muscle invasive, non-muscle invasive, and variant histology
- Patient electing to undergo radical cystectomy with bilateral pelvic lymphadenectomy after counseling with a urologic oncologist.
Exclusion Criteria5
- Patients undergoing radical cystectomy for benign indications (e.g. chronic bladder pain, fistulas, severe lower urinary tract symptoms)
- Patients undergoing radical cystectomy for a non-bladder primary malignancy (e.g. rectal, colon, uterine cancers).
- Patients with extensive locally advanced disease necessitating a pelvic exenteration
- Contraindication to receiving home IVF therapy (i.e. pre-existing cardiac, renal, hepatic dysfunction)
- Unwilling or unable to participate in 30 and 90 day follow-up phone calls.
Interventions
At home, the patient receives a 1L bolus of either lactated ringers or normal saline three times a week for four weeks with the patient's home nurse.
Patients assigned to not receive home IVF will receive everything in the investigator's current ERAS protocol except the home intravenous fluid program. Patients without preexisting vascular access will not receive a midline catheter post-operatively, however the participant will still receive home care for skilled nursing who will provide wound care, ostomy teaching, and education about perioperative fluid management.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT07225205